Onychomycosis
Conditions
Brief summary
The purpose of this study is to determine whether low level laser light is effective in the treatment of toenail fungus.
Detailed description
An infection of toenail fungus, or onychomycosis, occurs when fungi infect one or more nails. As the nail fungus spreads deeper into the nail, it may cause nail discoloration, thickening and the development of crumbling edges, all of which can lead to an unsightly and potentially painful problem. Onychomycosis is difficult to treat, and infections recur easily. Toenail fungus affects approximately 23 million people in the US - about 10% of all adults. Currently available treatments for toenail fungus are lacking. Even the most effective oral medications are successful only about half of the time. Topical medications are successful less than 10% of the time. Recently, research has found laser therapy to show promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven treatments for toenail fungus which can have many side effects including serious ones such as liver toxicity, laser therapy presents minimal risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail. The laser light vaporizes the fungus while leaving the skin and surrounding tissue unharmed.
Interventions
DEVICEErchonia FX-405™ Laser
The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Onychomycosis present in at least one great toenail. * Disease involvement is at least 25%. * Subject is willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation. * Subject is willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation.
Exclusion criteria
* Spikes of disease extending to nail matrix. * Infection involving lunula, e.g., genetic nail disorders, primentary disorders. * Less than 2mm clear (unaffected) nail plate length beyond the proximal fold. * Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed). * Chronic plantar (moccasin) tinea pedis. * History of current or past psoriasis of the skin and/or nails. * Concurrent lichen planus. * Onychogryphosis. * Any of the following conditions of the great toenail: * proximal subungual onychomycosis * white superficial onychomycosis * dermatophytoma or yellow spike/streak * exclusively lateral disease * confounding problems/abnormalities of the great toenail(s). * Any abnormality that could prevent a normal appearing nail if clearing of infection is achieved. * Inability for the toenail to become normal in the opinion of the investigator. * History of multiple repeated failures with previous therapies for onychomycosis. * Trauma to the affected great toenail(s). * Use of oral antifungal agents in the past 6 months. * Use of topical antifungal agents in the past 1 month. * Prior surgical treatment of the affected great toe(s). * Cancer and/or treatment of any type of cancer within the last six months. * Peripheral vascular disease or peripheral circulatory impairment. * History of uncontrolled diabetes mellitus. * Known immunodeficiency. * Known sensitivity, or contraindication, to light therapy. * Pregnant, breast feeding, or planning pregnancy prior to the end of study participation. * Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. * Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements. * Involvement in litigation and/or receiving disability benefits related in any way to the parameters of the study. * Participation in a clinical study or other type of research in the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail | 12 weeks | Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success. Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Millimeter (mm) of Clear Nail Bed | 12 weeks | Millimeter (mm) of clear nail from the base of the toenail lunula was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success. |
| Change in Percent (%) of mm Clear Nail | 12 weeks | Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erchonia FX-405™ Laser The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW
Erchonia FX-405™ Laser: The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time. | 105 |
| Total | 105 |
Baseline characteristics
| Characteristic | Erchonia FX-405™ Laser |
|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 12.85 |
| Percent (%) Toenail Onychomycosis Disease Involvement | 57.39 percent of toenail STANDARD_DEVIATION 21.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 102 Participants |
| Region of Enrollment United States | 105 participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 105 |
| serious Total, serious adverse events | 0 / 105 |
Outcome results
Primary
Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail
Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success. Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia FX-405™ Laser | Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail | 65 percentage of toenails |
Secondary
Change in Millimeter (mm) of Clear Nail Bed
Millimeter (mm) of clear nail from the base of the toenail lunula was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia FX-405™ Laser | Change in Millimeter (mm) of Clear Nail Bed | 4.99 millilmeters | Standard Deviation 2.24 |
p-value: <0.0001t-test, 2 sided
Secondary
Change in Percent (%) of mm Clear Nail
Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia FX-405™ Laser | Change in Percent (%) of mm Clear Nail | 30.36 percentage of change in mm clear nail | Standard Deviation 19.43 |
Comparison: results at 12 weeks compared to baselinep-value: <0.0001t-test, 2 sided